Methods and Compositions for Treating Esophageal Diseases

Abstract

Compositions and methods for treating esophageal diseases are disclosed. More specifically, these methods may refer to the treament of esophageal varices and eosinophilic esophagitis using an oral suspension drug for humans. The oral suspension drug may include poloxamer f127 used as vehicle and budesonide as a corticosteroid. Poloxamer oral suspension may be administrated by swallowing the poloxamer oral suspension drug which may slide down through the esophageal and may be adhered in the affected site providing a longer residence time. Additionally, poloxamer oral suspension may be mixed with APIs such as antifungals, antibacterials, and corticosteroids, previously dissolved in a suitable liquid, such as water.

1 . A pharmaceutical composition for oral administration comprising
 (a) budesonide in a concentration of about 1 mg/10 ml to about 2 mg/10 ml; and   (b) about 5% to about 10% by weight poloxamer f127;   (c) imidurea; and   (d) optionally, an antimicrobial agent selected from the group consisting of methyl ester of p-hydroxybenzoic acid, propyl ester of p-hydroxybenzoic acid, sodium benzoate, sorbic acid, and combinations thereof.   
     
     
         2 . A composition according to  claim 1 , which is in the form of an oral suspension. 
     
     
         3 . A composition according to  claim 1 , which is in the form of a tablet. 
     
     
         4 . A composition according to  claim 1 , further comprising an antibacterial composition, an antifungal composition, a corticosteroid, an antiparasitic composition, or a combination thereof. 
     
     
         5 . A method of treating esophageal disease, comprising orally delivering to a patient an effective amount of a pharmaceutical composition that comprises budesonide and at least one poloxamer. 
     
     
         6 - 8 . (canceled) 
     
     
         9 . The method according to  claim 5 , wherein the pharmaceutical composition is administered once per day. 
     
     
         10 . The method according to  claim 5 , wherein the pharmaceutical composition is administered in multiple doses per day. 
     
     
         11 . The method according to  claim 5 , wherein the pharmaceutical composition is in the form of an oral suspension. 
     
     
         12 . The method according to  claim 5 , wherein the pharmaceutical composition is in the form of a tablet. 
     
     
         13 . The method according to  claim 5 , wherein the pharmaceutical composition further comprising an antibacterial composition, antimicrobial agent , an antifungal composition, a corticosteroid, an antiparasitic composition, or a combination thereof. 
     
     
         14 . (canceled) 
     
     
         15 . The composition according to  claim 1  further comprising a pH adjusting agent, preservative, emulsifier, opacifier, antioxidant, fragrance, colorant, gelling agent, thickening agent, stabilizer, or surfactant. 
     
     
         16 . The composition according to  claim 4 , wherein the antiviral agent is selected from the group consisting of abacavir, aciclovir, adefovir, amantadine, amprenavir, arbidol., atazanavir, artipla, brivudine, cidofovir, combivir, edoxudine, efavirenz, emtricitabine, enfuvirtide, entecavir, fomvirsen, fosamprenavir, foscarnet, fosfonet, ganciclovir, gardasil, ibacitabine, immunovir, idoxuridine, imiquimod, indinavir, inosine, integrase inhibitors, interferons, including interferon type III, interferon type II, interferon type I, lamivudine, lopinavir, loviride, MK-0518, maraviroc, moroxydine, nelfinavir, nevirapine, nexavir, nucleoside analogues, oseltamivir, penciclovir, peramivir, pleconaril, podophyllotoxin, protease inhibitors, reverse transcriptase inhibitors, ribavirin, rimantadine, ritonavir, saquinavir, stavudine, tenofovir, tenofovir disoproxil, tipranavir, trifluridine, trizivir, tromantadine, truvada, valganciclovir, vicriviroc, vidarabine, viramidine, zalcitabine, zanamivir, zidovudine, and combinations thereof. 
     
     
         17 . The composition according to  claim 4 , wherein the antibacterial agent is selected from the group consisting of amikacin, gentamicin, kanamycin, neomycin, netilmicin, streptomycin, tobramycin, paromomycin, geldanamycin, herbimycin, loracarbef, ertapenem, doripenem, imipenem, cilastatin, meropenem, cefadroxil, cefazolin, cefalotin, cefalexin, cefaclor, cefamandole, cefoxitin, defprozil, cefuroxime, cefixime, cefdinir, cefditoren, cefoperazone, cefotaxime, cefpodoxime, ceftazidime, ceftibuten, ceftizoxime, ceftriaxone, cefepime, ceftobiprole, teicoplanin, vancomycin, azithromycin, clarithromycin, dirithromycin, erythromycin, roxithromycin, troleandomycin, telithromycin, spectinomycin, aztreonam, amoxicillin, ampicillin, azlocillin, carbenicillin, cloxacillin, dicloxacillin, flucloxacillin, mezlocillin, meticillin, nafcillin, oxacillin, penicillin, piperacillin, ticarcillan, bacitracin, colistin, polymyxin B, ciprofloxacin, enoxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, trovfloxacin, mafenide, prontosil, sulfacetamide, sulfamethizole, sulfanimilimde, sulfasalazine, sulfisoxazole, trimetoprim, demeclocycline, doxycycline, minocycline, oxytetracycline, tetracycline, arsphenamine, chloramphenicol, clindamycin, lincomycin, ethambutol, fosfomycin, fusidic acid, furazolidone, isoniazid, linezolid, metronidazole, mupirocin, nitrofurantoin, platensimycin, pyrazinamide, quinuspristin/dalfopristin, rifampin, tinidazole, AL-15469A, AL-38905, and combinations thereof. 
     
     
         18 . The composition according to  claim 4 , wherein the antifungal agent is selected from the group consisting ofamrolfine, utenafine, naftifine, terbinafine, flucytosine, fluconazole, itraconazole, ketoconazole, posaconazole, ravuconazole, voriconazole, clotrimazole, econazole, miconazole, oxiconazole, sulconazole, terconazole, tioconazole, nikkomycin Z, caspofungin, micafungin, anidulafungin, amphotericin B, liposomal nystastin, pimaricin, griseofulvin, ciclopirox olamine, haloprogin, tolnaftate, undecylenate, clioquinol, and combinations thereof. 
     
     
         19 . The composition according to  claim 4 , wherein the antiparasitic agent is selected from the group consisting ofamitraz, amoscanate, avermectin, carbadox, diethylcarbamizine, dimetridazole, diminazene, ivermectin, macrofilaricide, malathion, mitaban, oxamniquine, permethrin, praziquantel, prantel pamoate, selamectin, sodium stibogluconate, thiabendazole, and combinations thereof. 
     
     
         20 . The composition according to  claim 4 , wherein the corticosteroid is selected from the group consisting ofhydrocortisone, prednisone, fluprednisolone, triamcinolone, dexamethasone, betamethasone, cortisone, prednilosone, methylprednisolone, fluocinolone acetonide, flurandrenolone acetonide, and fluorometholone.